Revolutionary technology that puts you in full command of distal locking

• The first and only virtual real-time imaging system for distal locking • For years, distal locking with the free-hand fluoroscopic method has been the standard of care—now there's a new standard • Not a new technique, but a brilliant new technology that offers full surgeon control, a reduction in radiation exposure, and shorter procedures • Works seamlessly with the proven TRIGEN Nail family: META-NAIL*, TAN*, FAN*, Humeral, Pediatric and Adolescent nails

A significant dose response causes increased risks For each rad of radiation exposure a surgeon receives in a lifetime, risks increase.

The National Council on Radiation Protection & Measurements (NCRP) recommends using as low as reasonably achievable (ALARA) levels of radiation8

Cost

The TRIGEN SURESHOT system helps increase efficiency and reduce variability with shorter procedures1 • The variability in procedure time for distal locking is due to the number of fluoroscopic images and the time it takes to precisely target and align the distal locking holes • The TRIGEN SURESHOT reduces variability in both alignment and procedure time, allowing surgeons, staff, and the OR to be deployed to other revenue-producing activities

White Paper prepared by the FDA and Center for Devices and Radiological Health

Through the initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA and our partners will work to measurably reduce unnecessary exposure to patients to radiation in CT, fluoroscopy, and nuclear medicine imaging exams.

Design and Technology

TRIGEN SURESHOT Design Rationale

Screw targeting during intramedullary nailing of long bone fractures can be a laborious process and is highly dependent upon flouro technicians, often becoming the most frustrating and time-consuming step of the procedure. The vast majority of surgeons use a fluoroscopic method reliant upon obtaining ‘perfect circles'. This technique requires assistance to hold the extremity in a specific position and expertise from the radiology technician. Additionally, this technique is characterized by a moderate learning curve with variable accuracy, the potential for screw malalignment and exposes the patient and surgical staff to radiation.

The TRIGEN SURESHOT Distal Targeting System utilises an electromagnetic field generator, a probe inserted into the nail, and virtual imaging to facilitate distal locking without fluoroscopy. This revolutionary system is radiation free, position independent, and provides 3D real time feedback of location and orientation of the drill relative to the nail interlocking hole to provide unsurpassed accuracy. The TRIGEN SURESHOT Distal Targeting System was designed to mimic the ‘perfect circle' technique and has virtually no learning curve.

In combination with the superior TRIGEN IM Nail System, the TRIGEN SURESHOT Distal Targeting System allows surgeons to exercise maximum operating room control, benefitting everyone including the patient and OR staff. TRIGEN SURESHOT delivers optimal outcomes by providing the surgeon maximum command during intramedullary nailing and by reducing radiation exposure, anesthesia time and time in the OR, all while increasing accuracy.

The TRIGEN SURESHOT Distal Targeting System is the revolutionary approach to distal locking and further establishes the TRIGEN IM Nail System as the driving force in advancing and improving the efficacy of intramedullary nailing.

Indications

TRIGEN SURESHOT Indications

The Smith & Nephew TRIGEN SURESHOT Distal Targeting System is intended to be an intraoperative image-guided localisation system. It is a computer-assisted orthopaedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew TRIGEN SURESHOT Targeting System V2.1 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate. An example of a surgical procedure includes but is not limited to locating and drilling the distal holes in an intramedullary nail.

Contraindications The screw targeting software application for this system is contraindicated for all IM nails other than Smith & Nephew TRIGEN META-NAIL, TAN, FAN, Humeral, Pediatric and Adolescent nails. Do not operate the TRIGEN SURESHOT Targeter within 200mm of an installed pacemaker. The magnetic field produced by the Targeter may interfere with the operation of the pacemaker.

Intended use The TRIGEN SURESHOT Distal Targeting System is only designed for use with the indicated implants and instruments. Implants and instruments must be used in accordance with the instructions, as described in this manual and/or in the non-navigated surgical procedure.

Training Only trained operators are allowed to use the TRIGEN SURESHOT Distal Targeting System. The various operating instructions must be fully read and understood as part of the training. If any part of the instructions is not clear, please contact your local representative.